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Panel to Discuss Northera, Zontivity, Xarelto

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/14-16/14 to discuss Chelsea Therapeuti...

FDA Proposes Changes for OTC Consumer Antiseptic Washes

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Federal Register Proposed rule: FDA proposes to amend a 1994 monograph to establish conditions under which OTC consumer antiseptic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Stanislaw R. Burzynski, Burzynski Research Institute, Green Planet, Manhattan Re...

Ikaria Continues to Protest GeNO Orphan Drug Designation

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Ikaria files a third supplement to its petition asking that FDA revoke its orphan drug designation for GeNOs nitric oxide product....

OIG Says FDA Must Continue FDASIA Implementation

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The HHS Inspector General says FDA must continue on its three-year program to implement provisions of the 2012 FDA Safety and Inno...

Public Citizen Complains About FDA Drug Compounding Position

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Public Citizen writes FDA asking it to stop making misleading statements about pharmacy compounding that could lead health care pr...

Alexion Updates Recall of 2 Soliris Lots

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Alexion Pharmaceuticals updates its earlier recall involving two lots of Soliris (eculizumab) concentrated solution for intravenou...

CDRH Tweaks Medical Device Recall Database

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CDRH says it has made improvements to several public medical device recall databases.

Genzyme, NORD Fund for Rare Disease Diagnostic Testing

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Genzyme and the National Organization for Rare Disorders create a fund to pay for standard diagnostic testing for people with myst...

FDA Amends Animal Drug Regs on Dairy Heifers and Bambermycins

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Federal Register Final rule: FDA is removing dairy replacement heifers from the pasture cattle class for which free-choice, loose-...